Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

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Abstract

Background

Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD).

Methods/design

The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community.

Discussion

The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies’ impact on clinical care and patients’ outcomes.

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Most cited references 31

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Functional status of elderly adults before and after initiation of dialysis.

Manjula Kurella Tamura, Kenneth E. Covinsky, Glenn Chertow … (2009)

It is unclear whether functional status before dialysis is maintained after the initiation of this therapy in elderly patients with end-stage renal disease (ESRD). Using a national registry of patients undergoing dialysis, which was linked to a national registry of nursing home residents, we identified all 3702 nursing home residents in the United States who were starting treatment with dialysis between June 1998 and October 2000 and for whom at least one measurement of functional status was available before the initiation of dialysis. Functional status was measured by assessing the degree of dependence in seven activities of daily living (on the Minimum Data Set-Activities of Daily Living [MDS-ADL] scale of 0 to 28 points, with higher scores indicating greater functional difficulty). The median MDS-ADL score increased from 12 during the 3 months before the initiation of dialysis to 16 during the 3 months after the initiation of dialysis. Three months after the initiation of dialysis, functional status had been maintained in 39% of nursing home residents, but by 12 months after the initiation of dialysis, 58% had died and predialysis functional status had been maintained in only 13%. In a random-effects model, the initiation of dialysis was associated with a sharp decline in functional status, indicated by an increase of 2.8 points in the MDS-ADL score (95% confidence interval [CI], 2.5 to 3.0); this decline was independent of age, sex, race, and functional-status trajectory before the initiation of dialysis. The decline in functional status associated with the initiation of dialysis remained substantial (1.7 points; 95% CI, 1.4 to 2.1), even after adjustment for the presence or absence of an accelerated functional decline during the 3-month period before the initiation of dialysis. Among nursing home residents with ESRD, the initiation of dialysis is associated with a substantial and sustained decline in functional status. 2009 Massachusetts Medical Society

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Regression analysis of grouped survival data with application to breast cancer data.

Jennifer Prentice, L Gloeckler (1978)

Use of the proportional hazards regression model (Cox 1972) substantially liberalized the analysis of censored survival data with covariates. Available procedures for estimation of the relative risk parameter, however, do not adequately handle grouped survival data, or large data sets with many tied failure times. The grouped data version of the proportional hazards model is proposed here for such estimation. Asymptotic likelihood results are given, both for the estimation of the regression coefficient and the survivor function. Some special results are given for testing the hypothesis of a zero regression coefficient which leads, for example, to a generalization of the log-rank test for the comparison of several survival curves. Application to breast cancer data, from the National Cancer Institute-sponsored End Results Group, indicates that previously noted race differences in breast cancer survival times are explained to a large extent by differences in disease extent and other demographic characteristics at diagnosis.

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Frailty, dialysis initiation, and mortality in end-stage renal disease.

Yeran Bao, Lorien Dalrymple, Glenn Chertow … (2012)

In light of the recent trend toward earlier dialysis initiation and its association with mortality among patients with end-stage renal disease, we hypothesized that frailty is associated with higher estimated glomerular filtration rate (eGFR) at dialysis start and may confound the relation between earlier dialysis initiation and mortality. We examined frailty among participants of the Comprehensive Dialysis Study (CDS), a special study of the US Renal Data System, which enrolled incident patients from September 1, 2005, through June 1, 2007. Patients were followed for vital status through September 30, 2009, and for time to first hospitalization through December 31, 2008. We used multivariate logistic regression to model the association of frailty with eGFR at dialysis start and proportional hazards regression to assess the outcomes of death or hospitalization. Among 1576 CDS participants included, the prevalence of frailty was 73%. In multivariate analysis, higher eGFR at dialysis initiation was associated with higher odds of frailty (odds ratio [OR], 1.44 [95% CI, 1.23-1.68] per 5 mL/min/1.73 m(2); P < .001). Frailty was independently associated with mortality (hazard ratio [HR], 1.57 [95% CI, 1.25-1.97]; P < .001) and time to first hospitalization (HR, 1.26 [95% CI, 1.09-1.45]; P < .001). While higher eGFR at dialysis initiation was associated with mortality (HR, 1.12 [95% CI, 1.02-1.23] per 5 mL/min/1.73 m(2); P = .02), the association was no longer statistically significant after frailty was accounted for (HR, 1.08 [95% CI, 0.98-1.19] per 5 mL/min/1.73 m(2); P = .11). Frailty is extremely common among patients starting dialysis in the United States and is associated with higher eGFR at dialysis initiation. Recognition of signs and symptoms of frailty by clinicians may prompt earlier initiation of dialysis and may explain, at least in part, the well-described association between eGFR at dialysis initiation and mortality.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Nephrol

Journal ID (iso-abbrev): BMC Nephrol

Title: BMC Nephrology

Publisher: BioMed Central

ISSN (Electronic): 1471-2369

Publication date Collection: 2012

Publication date (Electronic): 6 December 2012

Volume: 13

Page: 167

Affiliations

[1 ]Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205, USA

[2 ]Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA

[3 ]Division of Nephrology, University of Manitoba, Manitoba, Canada

[4 ]Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

[5 ]Division of Nephrology, University of Miami Miller School of Medicine, Miami, FL, USA

[6 ]Division of Nephrology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

[7 ]Division of Nephrology, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA, 02111, USA

[8 ]Chronic Disease Research Group, 914 South 8th Street, Minneapolis, MN, USA

[9 ]University of Minnesota, College of Pharmacy, 308 Harvard St. SE, Minneapolis, MN, 55455, USA

[10 ]Nephrology Center of Maryland, 5601 Loch Raven Boulevard, Baltimore, MD, 21239, USA

[11 ]Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

[12 ]San Francisco General Hospital and University of California, San Francisco, 1001 Potrero Avenue, San Francisco, CA, 94110, USA

[13 ]Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA

[14 ]Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

Article

Publisher ID: 1471-2369-13-167

DOI: 10.1186/1471-2369-13-167

PMC ID: 3554422

PubMed ID: 23217181

SO-VID: d39ca824-9076-4729-9003-f2cc88312759

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

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Abstract

Background

Methods/design

Discussion

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Karger: Nephrology

Most cited references 31

Functional status of elderly adults before and after initiation of dialysis.

Regression analysis of grouped survival data with application to breast cancer data.

Frailty, dialysis initiation, and mortality in end-stage renal disease.

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